Observational Study to Assess the Effect of the Accu-Chek® SugarView app on Subjects withType 2 Diabetes
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2022/06/043130
- Lead Sponsor
- Roche Diabetes Care India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1. Subject has provided his/her signed informed consent.
2. Subject is = 18 years of age
3. Subject is diagnosed with diabetes type 2 and currently on exercise, diet or single or dual agent anti-diabetic therapy (but not on insulin and anti-diabetic drug with an hypoglycemic risk profile such as sulfonylureas)
4. Need to be empowered for disease self-management
5. Willingness to adhere to the app
- Never used a blood glucose meter for self-testing of blood glucose before (SMBG naive)
6. Subject must have and can use a smartphone, and should complete training on usage of the application installed in smartphone
7. Subjects who are able to read and write in English language
8. Willing to participate in the study and comply with study procedures
9. Provide study demographics such as age, education level, gender, therapy type and occupation
10. Experienced in using apps; and were currently using apps installed on their smartphones
1. Subject is pregnant or breastfeeding
2. Subject has incarceration or vision impairment not correctable with glasses or contact lenses
3. Subject is diagnosed with any clinically significant condition (e.g. infectious disease,
major organ system disease, such as gastroparesis or renal disease, psychosis or cognitive impairment), at investigator’s discretion
4. Subject does undergo chemotherapy or radiation therapy (self-reported)
5. Subject is related to the investigator or research staff
6. Subject is using any other mobile device to monitor glucose levels
7. Subject shares phones with other persons
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the impact of the Accu-Chek SugarView mobile application on diabetes <br/ ><br>empowerment measured by the DES-SF questionnaire.Timepoint: Visit 2,3,5 & 6
- Secondary Outcome Measures
Name Time Method - DTSQ , Health literacy (HLQ) <br/ ><br>- Accu-Chek SugarView User Experience Questionnaire <br/ ><br>- Medication list (name of the drug, dosage, frequency)/therapy (including frequency <br/ ><br>and type of exercise/type diet) per subject and per population <br/ ><br>- BMI, blood pressure, self-reported diabetes related symptoms <br/ ><br>- Self-reported HbA1c <br/ ><br>- percentage of glucose readings in target range <br/ ><br>- plasma glucose measurements in the normal range <br/ ><br>In-app user parameter as well as individual subjects: <br/ ><br>- number of reached goals <br/ ><br>- number of tests done <br/ ><br>- number of invalid testing (fail safe error, error code) <br/ ><br>- chosen goal <br/ ><br>- number of measurements in each range <br/ ><br>- used smartphone type (vendor, model, model number, e.g. Samsung Galaxy S10 , <br/ ><br>model number found in the phone information) <br/ ><br>Timepoint: Visit 2,3,5 & 6